Abstract
The organization of a core data structure capable of accurately and efficiently reporting clinical submission data has been an often elusive objective for many clinical data managers. In addition, the arrival of computer assisted new drug applications (CANDAs) has reemphasized existing requirements and highlighted new integration problems. A single integrated clinical database (ICDB) is proposed as a solution and one proven integration methodology is presented which explains the complete process while detailing the most common problems encountered.
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